NCT03649711

Chronic Kidney Disease (CKD) Platelet Study

A Mechanistic Study in Patients With Non-Dialysis Chronic Kidney Disease to Investigate Altered Platelet Response to Antiplatelet Therapy (CKD-Platelet Study)

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 76 (actual)
• Sponsor: University of Arkansas · Academic / Other
• Sex: All
• Age: 18 Years – 91 Years
• Healthy volunteers: Accepted

Summary

This study evaluates how aspirin, clopidogrel and ticagrelor work in people with chronic kidney disease (CKD) compared to people with normal kidneys. In the first part of the study, half of CKD participants will be randomly assigned to ticagrelor and aspirin, while the other half will be assigned to clopidogrel and aspirin in a blinded fashion. The treatment duration will be two weeks. After recruiting CKD participants the investigator will recruit controls with normal kidney function that will receive only ticagrelor and aspirin for two weeks.

Detailed description

It is known that people with chronic kidney disease (CKD) are at higher risk to have heart and blood vessel problems like heart attack and stroke compared to people that do not have kidney problems. Aspirin, clopidogrel and ticagrelor prevent blood clots building up in the vessels. If a blood clot is present in one vessel, it could stop oxygen carrying blood to get to a specific organ, and that could cause problems like heart attack or stroke. There is very little knowledge about the way this group of medicines works in people with chronic kidney disease as well as it works in individuals with normal kidney function.

Conditions

• Chronic Kidney Diseases
• Heart Attack
• Stroke, Ischemic

Interventions

Type	Name	Description
DRUG	Ticagrelor 90mg	Ticagrelor Pill
DRUG	Clopidogrel 75mg	Clopidogrel Pill and a matching placebo to conceal frequency
DRUG	Aspirin 81 mg	Aspirin Pill

Timeline

• Start date: 2018-11-01
• Primary completion: 2021-09-02
• Completion: 2021-09-02
• First posted: 2018-08-28
• Last updated: 2022-12-29
• Results posted: 2022-12-29

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated drug study